(a) Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.
(b) Classification. Class II, subject to the following special controls:
(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with 801.109 of this chapter.
(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.